BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4137

    MDR report key: 1020714 · Received March 24, 2008

    Report

    Report Number
    1028232-2008-00272
    Event Type
    Injury
    Date Received
    March 24, 2008
    Date of Event
    January 4, 2008
    Report Date
    February 28, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFO THAT THIS RIGHT ATRIAL (RA) LEAD POST-IMPLANT DAY ONE, HAD UNDERSENSING AND HIGH THRESHOLD MEASUREMENTS. TECHNICAL SVCS (TS) RECOMMENDS HAVING A CHEST X-RAY DONE TO CHECK FOR RA LEAD DISLODGEMENT. CLINICAL EVIDENCE SUGGESTS THAT THE RA LEAD MAY BE DISLODGED. AS THE PRODUCT REMAINS IN SVC, IT WILL NOT BE EXPLANTED. TO DATE, NO ADVERSE PT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4137 PACER LEAD DTB BIOTRONIK GMBH AND CO 358764

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization